Trial of Afatinib in Pediatric Tumours

Completed · Phase 1/Phase 2

Conditions studied: Neuroectodermal Tumors, Rhabdomyosarcoma

In brief

Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types

Key facts

Study ID

NCT02372006

Run by

Boehringer Ingelheim

People needed

56

Starts

2015-04-29

Expected to finish

2020-08-05

Last updated by the study team

2021-03-04

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Paediatric patients aged 1 year to <18 years at the time of informed consent
• diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
• recurrent/refractory disease after they received at least one prior standard treatment regimen
• no effective conventional therapy exists
• Performance status >= 50% (Lansky for =<12ys; Karnofsky for >12ys)
• Further inclusion criteria apply

You may not qualify if…

• relevant toxicity from previous treatment
• known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis
• Further exclusion criteria apply

Where it is running

• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Universitätsklinikum Essen AöR — Essen, Germany
• Universitätsklinikum Tübingen — Tübingen, Germany
• Istituto G. Gaslini — Genova, Italy
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
• Azienda Ospedaliera Universitaria di Padova — Padova, Italy
• Osp. Pediatrico Bambin Gesù — Roma, Italy
• Erasmus MC - Sophia Kinderziekenhuis — Rotterdam, Netherlands
• Hospital Vall d'Hebron — Barcelona, Spain
• Hospital Infantil Universitario Niño Jesus — Madrid, Spain
• Birmingham Children's Hospital — Birmingham, United Kingdom
• Great Ormond Street Hospital — London, United Kingdom
• Royal Manchester Children's Hospital — Manchester, United Kingdom
• The Royal Marsden Hospital — Sutton, United Kingdom
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Sydney Childrens Hospital — Randwick, New South Wales, Australia
• AKH - Medical University of Vienna — Vienna, Austria
• St. Anna Children-Hospital, Children's Cancer Research, Wien — Vienna, Austria
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Rigshospitalet, København, Børneonkologisk Afsnit 5002 — København Ø, Denmark
• HOP Toulouse, Pédiat, Toulouse — Toulouse, Faroe Islands
• HOP Pellegrin — Bordeaux, France
• CTR Oscar Lambret — Lille, France

Full record on ClinicalTrials.gov

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